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Office of Research Uniformed Services University of the Health Sciences Steven G. Kaminsky, Ph.D. Vice President for Research 13 October 2011.

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Presentation on theme: "Office of Research Uniformed Services University of the Health Sciences Steven G. Kaminsky, Ph.D. Vice President for Research 13 October 2011."— Presentation transcript:

1 Office of Research Uniformed Services University of the Health Sciences Steven G. Kaminsky, Ph.D. Vice President for Research 13 October 2011

2 Organizational Chart for Vice President for Research VPRVice President for Research Deputy Director and Assistant Vice President for Research OPDOffice of Program Development OSPOffice of Sponsored Programs OSMOffice of Scientific Management ORCOffice of Regulatory Compliance HSP Human Subjects Protection IBCInstitutional Biosafety Committee AMUAnatomical Material Use ACUAnimal Care & Use BICBiomedical Instrumentation Center GPC Genomics Core FCC Flow Cytometry Core IMCImaging Core SBCStructural Biology Core TSN Tri-Service Nursing Research Program LAMLaboratory Animal Medicine AHDAnimal Husbandry Division VMDVeterinary Medicine Division VPD Veterinary Pathology Division VSDVeterinary Surgery Division CNRMCenter for Neuroscience and Regenerative Medicine Vice President for Research (VPR) Deputy Director Assistant Vice President for Research OSMOSPLAMTSNBIC HSP IBC AMU GPC FCC IMC VSD AHD VMD VPD ACU OPDORC CNRM SBC

3 Organizational Chart for Vice President for Research VPRVice President for Research Deputy Director and Assistant Vice President for Research OPDOffice of Program Development OSPOffice of Sponsored Programs OSMOffice of Scientific Management ORCOffice of Regulatory Compliance HSP Human Subjects Protection IBCInstitutional Biosafety Committee AMUAnatomical Material Use ACUAnimal Care & Use BICBiomedical Instrumentation Center GPC Genomics Core FCC Flow Cytometry Core IMCImaging Core SBCStructural Biology Core TSN Tri-Service Nursing Research Program LAMLaboratory Animal Medicine AHDAnimal Husbandry Division VMDVeterinary Medicine Division VPD Veterinary Pathology Division VSDVeterinary Surgery Division CNRMCenter for Neuroscience and Regenerative Medicine Vice President for Research (VPR) Deputy Director Assistant Vice President for Research OSMOSPLAMTSNBIC HSP IBC AMU GPC FCC IMC VSD AHD VMD VPD ACU OPDORC CNRM SBC

4 Office of Program Development (OPD) Susan B. Rasmussen, Ph.D. Director

5 Office of Program Development: Roles of the Intramural Research Program Enables USU faculty to begin research directed at maintaining a fit and healthy force Enables USU to recruit and retain high quality clinician-investigators and biomedical scientists Enhances USU facultys ability to compete for extramural research funds Supports training of the next generation of government medical research scientists and physicians with sound understanding of the scientific basis of good medicine Supports continued academic accreditation for the Universitys programs in higher education

6 Office of Program Development: Intramural Research Program Award TypeFunding CeilingProject Period Exploratory$75,000 per yearUp to 24 months Standards$20,000 per yearUp to 36 months Pilots$10,000 per yearUp to 24 months Instructional$10,000 per yearUp to 24 months Clinical Fellows$3,000 per yearUp to 24 months Graduate Students$2,500 per yearUp to 24 months Medical Students$1,000 per yearUp to 12 months Startup EquipmentNegotiated at hiring24 months Startup PersonnelNegotiated at hiring36 months Startup SuppliesNegotiated at hiringUp to 60 months

7 USU Intramural Program Evolution of Funding Pilot Standard Exploratory Extramural

8 Start Up Funding Year 1Year 2Year 3Year 4Year 5 Equipment Personnel Supplies Apply for Extramural Funding Eligible to apply for Standard Intramural Funding Mr. Steve Rice VP of Finance Dr. Steve Kaminsky VP of Research OR

9 Organizational Chart for Vice President for Research VPRVice President for Research Deputy Director and Assistant Vice President for Research OPDOffice of Program Development OSPOffice of Sponsored Programs OSMOffice of Scientific Management ORCOffice of Regulatory Compliance HSP Human Subjects Protection IBCInstitutional Biosafety Committee AMUAnatomical Material Use ACUAnimal Care & Use BICBiomedical Instrumentation Center GPC Genomics Core FCC Flow Cytometry Core IMCImaging Core SBCStructural Biology Core TSN Tri-Service Nursing Research Program LAMLaboratory Animal Medicine AHDAnimal Husbandry Division VMDVeterinary Medicine Division VPD Veterinary Pathology Division VSDVeterinary Surgery Division CNRMCenter for Neuroscience and Regenerative Medicine Vice President for Research (VPR) Deputy Director Assistant Vice President for Research OSMOSPLAMTSNBIC HSP IBC AMU GPC FCC IMC VSD AHD VMD VPD ACU OPDORC CNRM SBC

10 Office of Sponsored Programs (OSP) Toya V. Randolph, Ph.D., MSPH Director

11 USU OSP – Overview & Mission Oversees administrative activities related to the pre- and post- award management of extramural research projects for USU faculty & AFRRI scientists Strives to provide friendly, efficient, courteous, & knowledgeable service Team of Grants Management Specialists to assist with extramural application submissions Each department has an assigned Specialist Works with the Henry M. Jackson Foundation for a smooth and efficient transition of USU applications & awards Open door policy

12 Henry M. Jackson Foundation Created in 1983 as a non-profit corporation Chartered by Congress to promote the welfare of the Uniformed Services University… – Supports many USU research projects – Over 400 employees at USU, more than 80 with Visas –Including Sponsored Project Administrators (SPA) for every academic department at USU Technology Transfer Located 6 miles north of USU on Rockledge Drive

13 HJF Contacts Betsy Folk VP Office of Sponsored Projects Alyssa Shepard, Ph.D. Director, USU Services or

14 Extramural Funding Submission Process PI writes grant PI works with Dept. SPA who works with USU Office of Sponsored Programs (OSP) & HJF OSP when appropriate USU OSP administrative review Revisions needed PI makes necessary revisions or provides additional documents PI submits revised documents Review & approval by Director, OSP No revisions needed USU OSP sends site approval to HJF OSP when appropriate HJF submits application to sponsor PI submits directly to sponsor USU OSP sends site approval to PI & SPA

15 Organizational Chart for Vice President for Research VPRVice President for Research Deputy Director and Assistant Vice President for Research OPDOffice of Program Development OSPOffice of Sponsored Programs OSMOffice of Scientific Management ORCOffice of Regulatory Compliance HSP Human Subjects Protection IBCInstitutional Biosafety Committee AMUAnatomical Material Use ACUAnimal Care & Use BICBiomedical Instrumentation Center GPC Genomics Core FCC Flow Cytometry Core IMCImaging Core SBCStructural Biology Core TSN Tri-Service Nursing Research Program LAMLaboratory Animal Medicine AHDAnimal Husbandry Division VMDVeterinary Medicine Division VPD Veterinary Pathology Division VSDVeterinary Surgery Division CNRMCenter for Neuroscience and Regenerative Medicine Vice President for Research (VPR) Deputy Director Assistant Vice President for Research OSMOSPLAMTSNBIC HSP IBC AMU GPC FCC IMC VSD AHD VMD VPD ACU OPDORC CNRM SBC

16 Institutional Review Board (IRB) Ms. Maggie Pickerel, CIP Director, Human Research Protections Program IRB Office (A2051)

17 IRB Chair: IRB #1 Edmund (Randy) Howe, M.D., J.D IRB #1 Administrator Micah Stretch, J.D Chair: ID IRB CAPT Trueman Sharp, MC, USN ID IRB Administrator Vicki Zajack, MPH, CIP

18 IRB: Roles and Functions Protects the rights and welfare of human research subjects Reviews research protocols to assess risks and benefits to subjects in research Ensures risks are minimized and reasonable in relationship to anticipated benefits Ensures voluntary participation of research, equitable selection, and informed consent Ensures compliance with DoD and federal regulations Recommends approval, disapproval, modification, tabling of protocols

19 IRB: PIs Role Submit protocol and related paperwork via IRBNet Use only the latest forms (located on IRBNet) -- no other forms permissible Ensure paperwork is complete -- Only complete paperwork will be reviewed List only one PI on the protocol (others are AIs/collaborators) Ensure congruence between funded grant and protocol Be aware of DoD unique regulations: e.g., no waiver of informed consent for experimental subjects; intent to benefit for subjects unable to provide consent; research monitor for more than minimal risk research; special permission for USU uniformed students as subjects, etc. Meet with IRB staff early for guidance, especially for multisite and protocols conducted offsite

20 IRB Facts USU has 2 IRBs: IRB #1 and the (central) Infectious Disease IRB Scheduled meetings: 2 nd or 3 rd Thursday Types of Protocol Review: Exempt, Expedited, Full Board, Non-human Subjects Research (NHSR) Exemption/NHSR determination made only by USU Exemption Determination Official (EDO) IRB = Privacy Board for HIPAA & Privacy Act issues Review/approval times depend upon protocol complexity, scheduling, workload, etc. Initial and continuing training required of all key research team members (initial: Secondary IRB review process required for research performed offsite (e.g., WRNMMC)

21 Organizational Chart for Vice President for Research VPRVice President for Research Deputy Director and Assistant Vice President for Research OPDOffice of Program Development OSPOffice of Sponsored Programs OSMOffice of Scientific Management ORCOffice of Regulatory Compliance HSP Human Subjects Protection IBCInstitutional Biosafety Committee AMUAnatomical Material Use ACUAnimal Care & Use BICBiomedical Instrumentation Center GPC Genomics Core FCC Flow Cytometry Core IMCImaging Core SBCStructural Biology Core TSN Tri-Service Nursing Research Program LAMLaboratory Animal Medicine AHDAnimal Husbandry Division VMDVeterinary Medicine Division VPD Veterinary Pathology Division VSDVeterinary Surgery Division CNRMCenter for Neuroscience and Regenerative Medicine Vice President for Research (VPR) Deputy Director Assistant Vice President for Research OSMOSPLAMTSNBIC HSP IBC AMU GPC FCC IMC VSD AHD VMD VPD ACU OPDORC CNRM SBC

22 Institutional Biosafety Committee (IBC) Chair Dr. Gabriela Dveksler Dept of Pathology Peter Bouma Biosafety Officer Ms. Melanie Hazzard Regulatory Affairs Coordinator

23 Institutional Biosafety Committee (IBC) Ensures compliance with NIH Guidelines Reviews protocols with rDNA & pathogens Appendix 4 of USUHS Assurance Supplement

24 EHS Webpage You can find the following: Lab Safety Information & Guidance Training Presentations Access to EHS Assistant Training records Chem & Bio Inventory Radiation records Report an Injury Forms & USUHS Instructions Waste management Contact Information

25 Organizational Chart for Vice President for Research VPRVice President for Research Deputy Director and Assistant Vice President for Research OPDOffice of Program Development OSPOffice of Sponsored Programs OSMOffice of Scientific Management ORCOffice of Regulatory Compliance HSP Human Subjects Protection IBCInstitutional Biosafety Committee AMUAnatomical Material Use ACUAnimal Care & Use BICBiomedical Instrumentation Center GPC Genomics Core FCC Flow Cytometry Core IMCImaging Core SBCStructural Biology Core TSN Tri-Service Nursing Research Program LAMLaboratory Animal Medicine AHDAnimal Husbandry Division VMDVeterinary Medicine Division VPD Veterinary Pathology Division VSDVeterinary Surgery Division CNRMCenter for Neuroscience and Regenerative Medicine Vice President for Research (VPR) Deputy Director Assistant Vice President for Research OSMOSPLAMTSNBIC HSP IBC AMU GPC FCC IMC VSD AHD VMD VPD ACU OPDORC CNRM SBC

26 Anatomical Material Review Committee (AMRC) Chair Alan Seyfer, M.D. Department of Anatomy, Physiology and Genetics Ms. Melanie Hazzard Regulatory Affairs Coordinator (301)

27 AMRC Reviews the use of human materials in education and research conducted within the Anatomic Teaching Laboratory to ensure that it conforms to the mission of the University and to the appropriate ethical, institutional, and regulatory standards Meetings held at least quarterly (6/year typical)

28 Organizational Chart for Vice President for Research VPRVice President for Research Deputy Director and Assistant Vice President for Research OPDOffice of Program Development OSPOffice of Sponsored Programs OSMOffice of Scientific Management ORCOffice of Regulatory Compliance HSP Human Subjects Protection IBCInstitutional Biosafety Committee AMUAnatomical Material Use ACUAnimal Care & Use BICBiomedical Instrumentation Center GPC Genomics Core FCC Flow Cytometry Core IMCImaging Core SBCStructural Biology Core TSN Tri-Service Nursing Research Program LAMLaboratory Animal Medicine AHDAnimal Husbandry Division VMDVeterinary Medicine Division VPD Veterinary Pathology Division VSDVeterinary Surgery Division CNRMCenter for Neuroscience and Regenerative Medicine Vice President for Research (VPR) Deputy Director Assistant Vice President for Research OSMOSPLAMTSNBIC HSP IBC AMU GPC FCC IMC VSD AHD VMD VPD ACU OPDORC CNRM SBC

29 Institutional Animal Use and Care Committee (IACUC) IACUC Chair Brian Cox, Ph.D. Dept. of Pharmacology IACUC Administrator Ms. Megan Ralls IACUC Coordinator Ms. Susan Hunt

30 IACUCs Roles and Functions Reviews animal use protocols Reviews significant changes to protocols Monitors animal care and use program Ensures PI and University compliance with animal welfare regulations Inspects CAF and labs with animals 2/year Reviews concerns about animal care/use Reports out noncompliance and suspensions to OLAW and ASD(HA)

31 IACUC: PIs Role Describe use of animals in grant application(s) Obtain IACUC approval prior to using animals or implementing significant protocol changes Ensure research is conducted in accordance with the protocol Comply with institutional policies and procedures Submit amendments for any major changes, including any change in scope of work Address significant changes in the progress report

32 IACUC Facts Meetings held monthly (3 rd Wednesday) Much routine business conducted electronically via New protocols have mandatory vet review before IACUC review Protocol approval is for 3 years Annual review must be performed to ensure protocol compliance

33 Organizational Chart for Vice President for Research VPRVice President for Research Deputy Director and Assistant Vice President for Research OPDOffice of Program Development OSPOffice of Sponsored Programs OSMOffice of Scientific Management ORCOffice of Regulatory Compliance HSP Human Subjects Protection IBCInstitutional Biosafety Committee AMUAnatomical Material Use ACUAnimal Care & Use BICBiomedical Instrumentation Center GPC Genomics Core FCC Flow Cytometry Core IMCImaging Core SBCStructural Biology Core TSN Tri-Service Nursing Research Program LAMLaboratory Animal Medicine AHDAnimal Husbandry Division VMDVeterinary Medicine Division VPD Veterinary Pathology Division VSDVeterinary Surgery Division CNRMCenter for Neuroscience and Regenerative Medicine Vice President for Research (VPR) Deputy Director Assistant Vice President for Research OSMOSPLAMTSNBIC HSP IBC AMU GPC FCC IMC VSD AHD VMD VPD ACU OPDORC CNRM SBC

34 Laboratory of Animal Medicine (LAM) LTC Timothy Settle, DVM, DACVPM, DACLAM Director

35 LAM Resources Available Conventional Multispecies housing Barrier housing for rodents Surgery suites for research and teaching Surgery & Anesthesia technical assistance Fluoroscopy Necropsy TBI & procedure rooms

36 LAM Services Available: Protocol & Animal model development Protocol veterinary pre-IACUC review Animal procurement Animal quality assurance and quarantine Animal housing and sanitation Animal husbandry & health care

37 Organizational Chart for Vice President for Research VPRVice President for Research Deputy Director and Assistant Vice President for Research OPDOffice of Program Development OSPOffice of Sponsored Programs OSMOffice of Scientific Management ORCOffice of Regulatory Compliance HSP Human Subjects Protection IBCInstitutional Biosafety Committee AMUAnatomical Material Use ACUAnimal Care & Use BIC Biomedical Instrumentation Center GPC Genomics Core FCC Flow Cytometry Core IMC Imaging Core SBC Structural Biology Core TSN Tri-Service Nursing Research Program LAMLaboratory Animal Medicine AHDAnimal Husbandry Division VMDVeterinary Medicine Division VPD Veterinary Pathology Division VSDVeterinary Surgery Division CNRMCenter for Neuroscience and Regenerative Medicine Vice President for Research (VPR) Deputy Director Assistant Vice President for Research OSMOSPLAMTSNBIC HSP IBC AMU GPC FCC IMC VSD AHD VMD VPD ACU OPDORC CNRM SBC

38 Biomedical Instrumentation Center (BIC) LTC Felicia Langel, V.M.D., Ph.D. Director

39 Biomedical Instrumentation Center (BIC) BIC is the shared instrument facility for USU. Open to all members of the USU community. Nominal fee-for-service From full service to user-independent service, depending on the instrument and the users level of training. Provide expertise in protocol design. Provide assistance with data collection and analysis.

40 Biomedical Instrumentation Center (BIC) Genomics DNA/RNA sequencing and synthesis Microscopic Imaging Fixed and live microscopy Flow Cytometry Fixed and live cell analysis and sorting Histopathology Preparation of fixed and frozen tissues for microscopy Structural Biology/Proteomics Molecular structure studies and protein/protein interactions Translational Imaging In vivo and ex vivo MRI and PET/CT

41 Joint Office of Technology Transfer (JOTT) USU Office of Research USU Office of Research HJF General Counsel

42 Joint Office of Technology Transfer (JOTT) Katie Swanson-Lipka, Ph.D. Technology Transfer Director (USU Office) (HJF HQ)

43 Joint Office of Technology Transfer (JOTT) Agatha Lee, Ph.D. Technology Transfer Liaison (USU) (HJF)

44 What Function does the Joint Office of Technology Transfer Serve? To protect and commercialize novel technologies developed by USU and HJF researchers Research Inventions Patents Commercialization How? Negotiating agreements affecting technology transfer Evaluating new invention disclosures Filing and prosecuting patent applications on novel inventions Marketing and licensing novel technologies - Including biological materials

45 Technology Transfer Services Material transfer agreements (MTA) Cooperative research and development agreements (CRADA) Nondisclosure agreements (NDA) Patent applications License agreements Royalty payments 8

46 Any Questions? 8

47 47

48 Henry M. Jackson Foundation Created in 1983 as a non-profit corporation Chartered by Congress to promote the welfare of the Uniformed Services University… – Supports over 200 research projects at USU – Over 400 employees at USU, more than 80 with Visas – Administers more than 100 education funds and 70 endowments Located 6 miles north of USU on Rockville Pike 5

49 HJF Support to USU Grant proposal submission assistance Post-award management – Human resources - recruiting, payroll, benefits, visas – Purchasing and vendor payments – Sub-award/sub-contract management – Financial management - 24/7 online reporting – Travel, graphics, communications services Education/endowment fund management Technology transfer 5

50 HJF Sponsored Project Administrators Every department has a Sponsored Project Administrator (SPA) Salary supported by onsite indirect cost recovery SPAs support investigators with proposal development and submission and post-award administration SPAs act as liaison between investigator, USU and HJF administration 6

51 What is a Patent? A Patent is a 20-year monopoly to prevent others from making, using or selling the patented invention without permission What is a patentable invention depends on many factors and is ultimately determined by the U.S. Patent and Trademark Office

52 What are the Criteria for a Patent? NOVEL - The invention must be demonstrably different from prior art (Publicly available ideas, inventions, products) USEFUL - The invention must have some application or utility or be an improvement WRITTEN DESCRIPTION – Sufficient detail so that a person having ordinary skill in the art can make and use the invention NON-OBVIOUS* - The invention cannot be obvious to a person of Ordinary Skill in the field when viewed in light of prior art * This is the most frequently cited reason by patent examiners as to why an invention is not patentable

53 The Importance of Record Keeping Patents in the U.S. Are Granted to Those Who First Conceptualize an Invention and Reduce It to Practice Important to Document and Date Conception of the Invention Reduction of the Idea to Practice Use Bound Notebooks and Ink Each Page Signed, Dated, and Witnessed

54 Patenting and Public Disclosures Public Disclosures - Publications (Papers and Abstracts), Presentations, Posters, Seminars, Internet Postings, etc. U.S. - Can apply for a patent no later than 1 year after public disclosure Foreign - Rights are lost once a public disclosure is made unless a prior patent filing has been made Commercial value of inventions enhanced with worldwide patent protection

55 Inventor Participation Increases the Probability of Success Inventor participates in drafting initial patent application by interacting with outside patent counsel Inventor participates throughout patent prosecution process Assists in addressing office actions from patent office Adding additional data and new claims to the application Inventor participation during commercialization Inventor assists in preparing non-confidential summaries of invention Inventors are often the best source to identify licensees Inventor participates in technical discussions with potential licensees CRADAs with licensee or potential licensee Bring research money to the laboratory


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